Drug Advertising and Side-Effect Information

Everyone who watches TV has seen ads for "new" drugs with 10 seconds of why it's the best thing since sliced bread, and 20 seconds of side-effects including-but-not-limited-to death, deathiness and death-like symptoms. Kidding.

This should raise several important questions.

First, why do drug companies keep running these obnoxious ads?  Because they keep working (pdf).  Despite their disagreeable qualities, most patients who see the ads ask for a prescription for the drug and most doctors who are asked to prescribe it will do so.  Why?  Most patients are hopeful that something "new" may help them, and most doctors find it faster and easier to say yes than to explain no.

Also, ads should raise the question of how is this drug "new'?  Depends on how you define it.  Drugs advertised on TV are certainly not generics: they are newly developed and approved drugs that will therefore be expensive.  On the other hand, only 10% of them will be new insofar as being the first ever of their kind, or better than already available drugs that do the same thing (congeners).  The other 90% are what is known in the trade as "me-too" drugs.  They are no better than older generically available drugs, and are being sold in hopes of obtaining market share for the drug company that makes them.

Last and not least, I get the most questions on side-effects.  The questions are basically around what are the side effects, and how bad are they.

Listed side effects are not inevitable.  They are simply a list of possible side effects.  WebMD does a great job in discussing what side effects actually are and how they can occur.

Common side-effects may occur in up to 10% of people who take a medication. This also means that 90% of people who take the medication experience no side effects.  Severe side-effects are far less likely to occur, as the FDA does not permit the sale of medications that are seen to frequently cause severe side-effects.

The tricky bit is trying to find out for yourself what side effects actually can happen with a medication, and also how commonly they actually occur.

The problem is that the information provided by pharmacies or in with the medications is largely provided by lawyers, and not by doctors or pharmacists or nurses.  The PI (Product Insert) is principally designed to prevent class action lawsuits by listing every possible reaction to the medication  to prevent you from being able to sue for failure to disclose ("You didn't tell me that could happen.").

It would be helpful if the PI also told you how often the side effect actually happens, whether it's real or theoretical, whether it happens in humans or only in test animals and whether it happens in patients like you, or only in ICU patients with organ transplants receiving the medication in their iv (not kidding).  Problem is, they don't.  The PI is not written to inform you, it is written to protect drug companies.  The much-vaunted PDR (Physician's Desk Reference) is simply a copy of PI's from all medications.

There is no shortage of information from sites such as drugs.com which do a pretty good job of providing useful information in plain English about medications.  However, I've still never seen one that tells you how common the side effects actually are with numbers.  Sorry, but it matters.  You might be okay with a medication where dizziness occurs in 1 in 10,000 people, but not so much if it were occurring in 10% of people.

Sider 2 is useful in getting that information.  Its A-Z listing shows side effects in color-coded columns from most common to least common and allows you at a glance to see if a side effect is common or rare and also percentage of occurrence by the color coding in the sidebar.

Micromedex is the first (or second) most widely used medication database used by doctors and pharmacists.  It's smartphone app is available for only $2.99/year. It does a superb job in easily presenting drug information including actual occurrence rates of side-effects.  However, it is targeted to doctors and pharmacists.  If you want to use it, you'll need a medical dictionary at your side to translate it.  Sorry, we say rhinorrhea and you say runny nose.

Low FODMAP Diets

Certain types of foods may cause digestive symptoms we commonly associate with Irritable Bowel Syndrome (IBS)  and gluten intolerance.

IBS is a real problem involving heightened sensitivity to digestive system distension or fullness, which can result in abdominal discomfort, nausea, bloating and diarrhea.

Celiac disease (also known as sprue) is a reaction to gluten (a wheat protein) resulting in progressive injury to the absorptive lining of the gut.  Around 1% of people have celiac disease. On the other hand, many more people report chronic abdominal discomfort, bloating or diarrhea which is alleviated by avoidance of gluten, even though they are proved not to have true celiac disease.

Two researchers at Monash University in Australia since 1999 (a dietician and a gastroenterologist) have found that certain types of foods may be fermented and/or poorly absorbed and could be responsible for these sort of non-specific, hard-to-pin-down symptoms.  The term FODMAP is now becoming more widely known as a result of their work.

FODMAP is acronymic for:

• Fermentable
• Oligosaccharides,
• Disaccharides,
• Monosaccharides
• And
• Polyols.

This handout (pdf) from the Canadian Digestive Health Foundation breaks this down, and further describes what these chemicals are very nicely.

Basically, some naturally occurring carbohydrates such as lactose (milk sugar), fructose (fruit sugar), the fructans in onion, garlic and wheat and galactans in beans can be fermented during digestion leading to discomfort, nausea and bloating. 

Additionally, some of these are not readily absorbed and can lead to water being drawn in to the colon before elimination resulting in diarrhea.  This latter is particularly true of synthetic sweetening polyols such as sorbitol or xylitol which are used to artificially sweeten foods, chewing gum and other products.

Mind you, we're talking about naturally-occurring constituents of common foods.  Some foods contain more of these than others.  For example, fructans are more abundant in wheat and rye than in rice or oats.  Similarly, apples and mangos contain more fructose than bananas or berries.

This pamphlet (pdf) from Stanford University Medical Center nicely shows within the FODMAP's, which foods to limit and which are okay.

If you feel that your digestive symptoms may be affected by dietary FODMAP's you can systematically limit dietary FODMAP's one group at a time for a few weeks to determine which group or groups you may wish to limit long-term.

Alternatively, you can limit all six groups at once.  If you notice improvement, you can then de-limit one group at a time to identify culprit groups.

Please note this is quite effective with limiting intake of culpable types of FODMAP's.  Absolute avoidance is not generally necessary.

(Also, we are just discussing food substances resulting in fermentation and poor absorption. 

Other digestive symptoms such as fever, weight loss, appetite loss, stringy bowel movements, blood or mucus in your bowel movements are warning signs of much more significant problems such as infections or cancers.  Please see me for such symptoms as soon as possible, and do not try to treat them with a reduced FODMAP diet.)

Interesting Perspectives on the Changes in Medical Practice and Ethics

Unless you are a close student of history or of a certain age (*cough*), you probably don't fully realize how much the current practice of medicine really dates from the civil rights movements of the 1960's and 1970's, and how different this is from previously.

Until quite recently, the ethical principle of benificence (or paternalism, as it is also known) was the standard.  This meant that the  doctor was understood to be a professional with a deep understanding of a complex body of knowledge whose duty was to make complex decisions for patients with the best interests of the patient in mind.  Please note that the "decider" is the doctor and that the doctor also determined what was in the patient's interests. 

This article by James Hamblin in The Atlantic is an interview with Barron Lerner, whose father was an infectious disease specialist in the 1950's.  The interview is in the setting of a book written by him on the evolution of medical ethics from the reflections of he and his father, both of whom are doctors.

A part of the civil rights and free speech movements was the development of ethical autonomy, in which the doctor and the patient are understood to be shared decision-makers.  The physician is there to provide expert knowledge and experience, and to provide and describe a full range of options to allow the patient to be as fully informed as possible and to be able to decide for him/herself what is the best course of action.

Hamblin's article nicely addresses the intersection of autonomy with real concerns like time and differences of goals or opinions.  I'm sure every doctor has had cases where they have felt that the patient was making a truly bad decision, and I'm equally sure every patient has had visits or encounters where they've simply wished the doctor would just get to the point and tell them what needed to be done.  And time certainly is a factor.  Fully investigating the medical concerns at hand, performing a physical examination (yes, a good directed physical examination is still valuable and helpful in arriving at a diagnosis, but it does take time) and then fully describing the range of diagnostic and treatment options, their upside and downside risks and fully answering all questions and concerns is pretty near impossible to do in fifteen minutes in all but the most straightforward problems or concerns.  This is of course coupled with patient focus-grouping which reveals the importance of completeness and length of time with the doctor.  And also promptness. Doh!  Hello, quality-control triangle!

This article by Brandon Cohen in Medscape talks about the elephant in the exam room.  Can ethical autonomy go to the extreme of consumerism?  Is medicine another service in which customer satisfaction trumps the actual quality of the service?  Are HealthGrades reviews of doctors just like Yelp reviews of restaurants (read closely how many negative restaurant reviews relate to dissatisfaction with wait service and not so much the actual quality of the food which is what restaurants provide)?  Which is more important: that patients get the best care and have the best health, or that they are personally satisfied?  When are these goals mutually exclusive and when are they not?

If it sounds like I have more questions on this than answers, that's because it's true.  I do know that it's not unusual for Canadians to come to the U.S. for knee replacement because it takes longer in Canada to get MRI's or surgery for chronic conditions.  I also know that Canadians live longer than Americans, and can get timely tests and treatment for serious problems.  I know that most patients complain about TV ads for medicines, but I also know that the ads still run because they work.  I know that a bad rating of a hospital may mean the hospital is really bad, but it also may mean they treat a lot of complicated patients with rare conditions that no one else can treat.

Sunscreens: Summer is definitely here!

If you follow the weather reports (or just step outside) you've noticed Summer is definitely on!

The liberal application of sunscreen every two hours can help to prevent sunburn, skin cancer and wrinkling of the skin.  This is especially important in children, since one single blistering sunburn can double the lifetime risk of melanoma.

Melinda Moyer at Slate Magazine covers (no pun) the topic quite nicely.  Briefly;

• Organic sunscreens are called this because they are carbon-based, and absorb UVA which causes cancer, and UVB which causes sunburn.  
• Mineral sunscreens accomplish this by reflecting UVA and UVB.
• SPF 30 blocks 97% of UVB, SPF 50 blocks 98%.  It's probably not necessary to get anything stronger than that.
• Spray-on, or wipe-on sunscreen may not cover your skin as well as lotions.
• Using combined sunscreen + insect repellent may increase the absorption of the chemicals into your bloodstream, which may not be a good idea.

Environmental Working Group (a non-profit organization) has a great website that provides plenty of information and recommendations on sunscreens and their ingredients, safety, quality and cost.

Their iPhone and Android apps, Skin Deep also makes this information accessible on sunscreens and also  cosmetics in a mobile platform.  You can browse by entering sunscreen as a search word, or barcode scan products at the store.